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AJJ Maternal and Fetal Monitor - HSA Registration DE0510437

Access comprehensive regulatory information for AJJ Maternal and Fetal Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510437 and owned by AJJ Healthcare Management Pte Ltd. The device was registered on March 07, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0510437
AJJ Maternal and Fetal Monitor
HSA Registration Number: DE0510437
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Product Description

Maternal and Fetal Monitor is intended for non-invasive monitoring of the Fetal Heart Rate(FHR) of single fetuses, twins (optional) or triplets (optional), Uterine Activity (UA), and Fetal Movement (FM).

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0510437
Registration Date
March 07, 2025
Retention Due Date
March 06, 2026
Product Owner
Short Name
AJJ Healthcare Management Pte Ltd
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Registrant
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Importer
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Model Information
Model Name(s)
Fetal Monitor Fetal Monitor Maternal and Fetal Monitor
Model Identifier(s)
AJJ-SRF618B5 AJJ-SRF618B6 AJJ-SRF618K9